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Longeveron Stock Forum
Longeveron Reports Positive FDA Type C Meeting on BLA Pathway for Lomecel-B in HLHS
The Phase 2B trial for the CLEAR MIND study, which evaluates Lomecel-B for mild Alzheimer's disease, is anticipated to start following a meeting with the FDA before the end of 2024. This meeting aims to outline the future clinical and regulatory strategy for Lomecel-B, based on the positive results from the Phase 2A trial. Specific timelines for initiating the Phase 2B trial will depend on t...
13/11/2024 - 05:05
Phase 2b clinical trial (ELPIS II) evaluating Lomecel-B™ in rare pediatric disease HLHS has achieved more than 80% enrollment
Positive Type C meeting with U.S. FDA confirmed ELPIS II is pivotal and, if positive, acceptable for Biological License Application (BLA) submission for full traditional approval
Positive data from the Phase 2a clinical trial (CLEAR MIND) eval...
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